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FDA 510(k)

EsophaCap 可吞咽性細胞回收設備（原名 Cell-Mata）

K 號：K203450 · 2021-05-04

申請人Capnostics, LLC
決定日期2021-05-04
產品代碼EOX
諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯： 此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。 公司名稱：[公司名稱] 產品名稱：[產品名稱]
決定相當於

器材摘要

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is the device name listed in this FDA 510(k) record. The listed applicant is Capnostics, LLC. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K203450. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Capnostics, LLC. The 510(k) number is K203450.

When did EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) receive FDA 510(k) clearance?

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) received FDA 510(k) clearance on 2021-05-04, under 510(k) number K203450.

Who is the listed applicant for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

The FDA 510(k) record lists Capnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)?

The FDA product code for EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is EOX.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EOX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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